Complete Summary of Knee Replacement Recalls 2017

The year 2017 saw a substantial number of knee replacement recalls by the FDA, all of which were classified as Class 2 device recalls. The FDA defines a Class 2 recall as “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”. An FDA recall order forces the manufacturer in question to take action towards addressing a problem with a certain device in violation of FDA law.

In addition to FDA forced recalls, medical device manufacturers may issue voluntary recalls in which a potential problem might risk their reputation. The list of knee replacement recalls for 2017 below consists of only FDA recalls.

Zimmer Biomet

Zimmer Biomet, the leading competitor in the knee replacement market, maintains a broad product portfolio that has won considerable popularity among consumers. The company’s leading market share in the knee replacement device market was largely attributed to its Persona ® The Personalized Knee System, which received approval from the FDA in 2013, as well as to the Oxford Partial Knee System which celebrated its 40th anniversary in 2016 and is the most widely used partial knee replacement system in the world. Other significant Zimmer Biomet brands include the Vanguard® Knee System and NexGen® Complete Knee Solution. However, along with their wide range of devices, the company was also subject to the largest number of FDA recalls in 2017.

Most notably, on February 22nd, Zimmer Biomet was issued a total of 5 recall orders pertaining to their Oxford product line due to potential alumina inclusion in the finished product that could lead to cracking and separation. Products affected included the Oxford Partial Knee System Right and Left Medial Tibial Tray (of various sizes), Femoral Slap Hammer and Tibial Resector Body Tube & Guides, as well as the Oxford Unicompartmental Knee Phase 3 Tibial Impactor and various polyethylene implants: Sports Med, Repicci II Tibial Components.

Other knee replacement recalls by Zimmer Biomet in 2017 included:

Date

January 6th, 2017

Reason for Recall

Mislabeling of right Oxford Fixed Lateral Bearings as left Bearing

Product(s) Affected

Oxford Fixed Lateral Bearing Size F Right

Date

January 28th, 2017

Reason for Recall

Drill bit larger than process specification

Product(s) Affected

Vanguard 360 Revision Knee System

Date

January 28th, 2017

Reason for Recall

Mislabeling of OSS Modular Proximal Tibia as AVL Modular Proximal Tibia which could lead to delay in surgery or revision

Product(s) Affected

Orthopedic Salvage System (OSS) 9cm

Date

February 16th, 2017

Reason for Recall

Potential alumina inclusion in finished product that could lead to cracking and separation

Smith & Nephew is another major competitor in the knee replacement market. The company’s sales in the market experienced massive growth in 2017, which was greatly attributed to their JOURNEY II Total Knee, as well as to the LEGION Revision Knee System and ANTHEM Total Knee System.

The iData series on the market for orthopedic large joint devices covers the U.S., India, Japan, China, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedics large joint replacement market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Orthopedic Large Joint Devices brochure and synopsis.

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